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Amphotericin B Cholesteryl Sulfate Complex Injection

[14 July 2014]

Products Affected - Description

Amphotec, lyophilized powder, Alkopharma
50 mg vial (NDC 66435-0301-51)
100 mg vial (NDC 66435-0302-01)

Reason for the Shortage

  • Kadmon had acquired Three Rivers Pharmaceuticals in October 2010 and Amphotec was part of the product portfolio.
  • Kadmon recently sold Amphotec to Alkopharma. Alkopharma is the sole supplier of amphotericin b cholesteryl sulfate lipid complex. The contracted manufacturer of Amphotec was Ben Venue Laboratories.
  • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.
  • The shortage of amphotericin b cholesteryl sulfate lipid complex is not affecting other amphotericin formulations.

Available Products

No presentations are available.

Estimated Resupply Dates

Amphotec is not available from Alkopharma. Contacts are unavailable to provide further availability.

Related Shortages

Updated

July 14, 2014; March 24, 2014; January 2, 2014; October 9, 2013; July 11, 2013; April 12, 2013; February 13, 2013; September 10, 2012; July 6, 2012; February 15, 2012, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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